FDA Pre-Cert

HIMSSCast: FDA grapples with home COVID-19 testing, moves forward with Pre-Cert Program
By HIMSS Media | 05:31 pm | March 30, 2020
The HIMSS Media team gives a recap of recent headlines surrounding the FDA, COVID-19 and new digital health software products.
FDA clears Pear's digital insomnia therapeutic through 510(k), Pre-Cert pilot pathways
By Dave Muoio | 04:53 pm | March 26, 2020
Somryst, a prescription digital therapeutic combining cognitive behavioral therapy and personalized sleep restriction, is the first software product to put the FDA's early Precertification Program framework through its paces. 
FDA Pre-Cert participants share early experiences
By Jonah Comstock | 04:15 pm | October 19, 2018
A collaborative attitude and a commitment to strenuous review have characterized the process so far.
Three Democratic Senators sent the agency a 12-page letter containing more than 50 questions about …
By Jonah Comstock | 04:02 pm | October 10, 2018
The FDA’s Pre-Cert program has fallen under new scrutiny as the agency received an open letter today from three senators: Elizabeth Warren (D-Mass.